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Blood Gas Analysis and Buffering In Cardiac Arrest (BABICA)

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Sodium bicarbonate
Sodium Chloride
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • prehospitally started cardiopulmonary resuscitation (CPR)
  • advanced cardiac life support provided
  • age >18 years
  • arterial pH < 7,2
  • arterial BE < -12
  • arterial pCO2 15-75 mmHg
  • arterial pO2 >35 mmHg

Exclusion Criteria:

  • women of childbearing age
  • traumatic cardiac arrest

Sites / Locations

  • Landeskrankenhaus Klagenfurt
  • Landesklinikum Wiener Neustadt
  • Landeskrankenhaus Bruck / Mur
  • LKH Graz West
  • Medical University Graz
  • AKH Linz

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Sodium Chloride

Sodium Bicarbonate

Arm Description

Group receiving sodium chloride 0.9% after arterial blood gas analysis in cardiac arrest.

Group receiving targeted sodium bicarbonate 8% therapy after arterial blood gas analysis in cardiac arrest.

Outcomes

Primary Outcome Measures

Rate of return of spontaneous circulation (ROSC)

Secondary Outcome Measures

Survival to discharge after cardiac arrest
Discharge from hospital
Survival after one year of hospital discharge

Full Information

First Posted
April 27, 2011
Last Updated
June 2, 2014
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT01362556
Brief Title
Blood Gas Analysis and Buffering In Cardiac Arrest
Acronym
BABICA
Official Title
Blood Gas Analysis and Buffering In Cardiac Arrest - A Multicenter, Prospective, Randomised, Double Blind Prehospital Trial to Evaluate the Impact of Early Blood-gas-analysis Targeted Buffer Therapy on ROSC After OOHCA
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Graz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The debate over the administration of sodium bicarbonate in cardiac arrest has been going on for several decades, swinging like a pendulum from "first-line drug" to "not indicated" to the recent guidelines advocating "a small bolus under special conditions (metabolic acidosis, intoxication, long-term resuscitation)". A targeted, blood-gas controlled application under optimised ventilation conditions has not yet been evaluated prehospitally. Our preliminary studies have shown that an arterial puncture/line as well as measurement of blood gases is feasible in preclinical conditions. This multicentre trial including 5 centres and 10 physician-staffed emergency systems is designed to compare, in a prospective randomised controlled study, the effect of a calculated dosage of sodium bicarbonate based on the patient´s base deficit and weight, on ROSC (= return of spontaneous circulation) and on the secondary survival of cardiac arrest patients. The null hypothesis is that there is no or negative impact on survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sodium Chloride
Arm Type
Placebo Comparator
Arm Description
Group receiving sodium chloride 0.9% after arterial blood gas analysis in cardiac arrest.
Arm Title
Sodium Bicarbonate
Arm Type
Active Comparator
Arm Description
Group receiving targeted sodium bicarbonate 8% therapy after arterial blood gas analysis in cardiac arrest.
Intervention Type
Drug
Intervention Name(s)
Sodium bicarbonate
Intervention Description
Administration of a calculated amount of sodium bicarbonate 8% [SB] after arterial blood gas measurement according to Base Excess [BE] and Body weight [kg]. Formula: SB [ml] = -BE * kg * 0.1
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride
Intervention Description
Administration of a calculated amount of sodium chloride 0.9% [SC] after arterial blood gas measurement according to Base Excess [BE] and Body weight [kg]. Formula: SC [ml] = -BE * kg * 0.1
Primary Outcome Measure Information:
Title
Rate of return of spontaneous circulation (ROSC)
Time Frame
Within five hours from start of resuscitation.
Secondary Outcome Measure Information:
Title
Survival to discharge after cardiac arrest
Description
Discharge from hospital
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Title
Survival after one year of hospital discharge
Time Frame
One year after event

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: prehospitally started cardiopulmonary resuscitation (CPR) advanced cardiac life support provided age >18 years arterial pH < 7,2 arterial BE < -12 arterial pCO2 15-75 mmHg arterial pO2 >35 mmHg Exclusion Criteria: women of childbearing age traumatic cardiac arrest
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Prause, Prof. Dr.
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Landeskrankenhaus Klagenfurt
City
Klagenfurt
State/Province
Carinthia
ZIP/Postal Code
9020
Country
Austria
Facility Name
Landesklinikum Wiener Neustadt
City
Wiener Neustadt
State/Province
Lower Austria
ZIP/Postal Code
2700
Country
Austria
Facility Name
Landeskrankenhaus Bruck / Mur
City
Bruck / Mur
State/Province
Styria
ZIP/Postal Code
8600
Country
Austria
Facility Name
LKH Graz West
City
Graz
State/Province
Styria
ZIP/Postal Code
8020
Country
Austria
Facility Name
Medical University Graz
City
Graz
State/Province
Styria
ZIP/Postal Code
8036
Country
Austria
Facility Name
AKH Linz
City
Linz
State/Province
Upper Austria
ZIP/Postal Code
4021
Country
Austria

12. IPD Sharing Statement

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Blood Gas Analysis and Buffering In Cardiac Arrest

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